Digital twins in pharmaceutical and biopharmaceutical manufacturing: a literature review

Y Chen, O Yang, C Sampat, P Bhalode… - Processes, 2020 - mdpi.com
The development and application of emerging technologies of Industry 4.0 enable the
realization of digital twins (DT), which facilitates the transformation of the manufacturing …

Bioprocessing in the digital age: the role of process models

H Narayanan, MF Luna, M von Stosch… - Biotechnology …, 2020 - Wiley Online Library
In this age of technology, the vision of manufacturing industries built of smart factories is not
a farfetched future. As a prerequisite for Industry 4.0, industrial sectors are moving towards …

[HTML][HTML] Perfusion mammalian cell culture for recombinant protein manufacturing–A critical review

JM Bielser, M Wolf, J Souquet, H Broly… - Biotechnology …, 2018 - Elsevier
The manufacturing of recombinant protein is traditionally divided in two main steps:
upstream (cell culture and synthesis of the target protein) and downstream (purification and …

Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing

KA Esmonde-White, M Cuellar, C Uerpmann… - Analytical and …, 2017 - Springer
Abstract Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process
analytical technology (PAT), and continuous manufacturing are major factors effecting new …

The role of Raman spectroscopy in biopharmaceuticals from development to manufacturing

KA Esmonde-White, M Cuellar, IR Lewis - Analytical and Bioanalytical …, 2022 - Springer
Biopharmaceuticals have revolutionized the field of medicine in the types of active
ingredient molecules and treatable indications. Adoption of Quality by Design and Process …

Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

DP Wasalathanthri, MS Rehmann… - Biotechnology and …, 2020 - Wiley Online Library
Real‐time monitoring of bioprocesses by the integration of analytics at critical unit
operations is one of the paramount necessities for quality by design manufacturing and real …

[HTML][HTML] Opportunities for applying biomedical production and manufacturing methods to the development of the clean meat industry

EA Specht, DR Welch, EMR Clayton… - Biochemical Engineering …, 2018 - Elsevier
Clean meat (meat grown in cell culture rather than obtained from animal slaughter) is an
emerging biotechnology industry that will ameliorate the serious environmental …

Applications of Raman spectroscopy in biopharmaceutical manufacturing: a short review

K Buckley, AG Ryder - Applied spectroscopy, 2017 - journals.sagepub.com
The production of active pharmaceutical ingredients (APIs) is currently undergoing its
biggest transformation in a century. The changes are based on the rapid and dramatic …

Scale-up technologies for the manufacture of adherent cells

CF Bellani, J Ajeian, L Duffy, M Miotto… - Frontiers in …, 2020 - frontiersin.org
Great importance is being given to the impact our food supply chain and consumers' food
habits are having on the environment, human health, and animal welfare. One of the latest …

Quality by control: Towards model predictive control of mammalian cell culture bioprocesses

W Sommeregger, B Sissolak, K Kandra… - Biotechnology …, 2017 - Wiley Online Library
The industrial production of complex biopharmaceuticals using recombinant mammalian cell
lines is still mainly built on a quality by testing approach, which is represented by fixed …